Drugs
Federal Register notice: FDA has announced a 6/12 public workshop entitled “Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities.” Mandated by the current user fee agreement, the workshop is intended to discuss challenges and opportunities (XXX DELETE XXX)in drug development and regulatory review.
Drugs
National Institutes of Health (NIH) director Francis Collins says a study funded by NIH that gathered survey data from over 27,000 people over a six-year period found that individuals who reported taking dietary supplements had about the same risk of dying as those who got their nutrients through
Drugs
With immunotherapeutics accounting for 21% of FDA’s oncology drug approvals in 2018, Oncology Center of Excellence director Richard Pazdur convened executives from six drug companies at an American Association for Cancer Research (AACR) annual meeting panel to discuss whether there are too many such drugs on the market. An
Drugs
FDA has granted Intensity Therapeutics a fast track designation for INT230-6 and its use treating patients with relapsed or metastatic triple negative breast cancer (TNBC) who have failed at least two prior lines of therapy. The company says TNBC is considered to be more aggressive and have a poorer
Drugs
Federal Register notice: FDA has announced it is withdrawing approval of 31 ANDAs from multiple applicants. The applicants notified the agency in writing that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
Drugs
Hi-Tech Pharmaceuticals, Norcross, GA, says a 4/10 FDA Warning Letter dealing with four of the company’s dietary supplements containing DMHA represents agency “bullying” attempts to “quasi ban a product by Warning Letter rather than rulemaking” and “is not the law.” The Warning Letter questions whether DMHA is
Drugs
The voluntary plan pushed by Pharmaceutical Research and Manufacturers of America (PhRMA) to give consumers more drug pricing information in direct-to-consumer TV ads is producing mixed results, according to an online analysis by Biopharmadive. The report says the ads generally contain a line of text directing viewers to
Drugs
FDA and George Washington University (GW) have published a BioCompute Object Specification document for research and clinical trial use, detailing a new framework for communication of high-throughput sequencing computations and data analysis, known as BioCompute Objects. Researchers at GW say the framework will allow researchers to share and compare
Drugs
Public Citizen is petitioning FDA to add a Boxed Warning to labeling for Amgen’s osteoporosis drug Prolia (denosumab) to describe the risk of vertebral fractures upon discontinuing the drug. The advocacy group’s 4/16 petition says “there is a growing body of evidence that cessation of Prolia is
Drugs
A 12/10-12/14/18 FDA inspection at Luen Fook Medicine, Johor, Malaysia, found significant violations of current good manufacturing practice (CGMP) regulations and manufacturing of an unapproved new drug. A 4/4 Warning Letter says specific violations were: * failing to have, for each batch of drug product, appropriate
Drugs
A 4/3-4/13/18 FDA inspection at RIJ Pharmaceutical, Middletown, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/28 Warning Letter says specific violations were: * failing to establish adequate written procedures for production and process control designed to assure that
Drugs
FDA has granted CRISPR Therapeutics and Vertex Pharmaceuticals a fast track designation for CTX001 for treating transfusion-dependent beta thalassemia (TDT). CTX001 is an investigational, autologous, gene-edited hematopoietic stem cell therapy for patients suffering from severe hemoglobinopathies. In February, CRISPR and Vertex announced that the first patient had been
Drugs
CDER says its statisticians are designing clinical trials with adaptive features to make clinical evaluation of new drug treatments more efficient and informative. In an online Regulatory Science Impact Story, Center officials describe the challenges involved in evaluating treatments for Ebola during the outbreak a few years ago. “A randomized
Drugs
FDA has posted a 3/14-completed Form 483 that includes nine observations from an inspection at Temple, TX-based QuVa Pharma. (XXX DELETE XXX)Agency investigators cited the firm for not having adequate written procedures to describe in sufficient detail the receipt, identification, approval, and rejection of components. The
Drugs
FDA has granted FibroGen an orphan drug designation for the company’s anti-connective tissue growth factor (CTGF) antibody, pamrevlumab, for treating patients with Duchenne muscular dystrophy (DMD). The designation is based on data from a Phase 2 study in 21 non-ambulatory DMD patients who have completed the first
Drugs
FDA has approved an expanded label for Merck’s Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with Stage 3 non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors
Drugs
Former Pharmakon Pharmaceuticals CEO Paul J. Elmer has been convicted of conspiracy to defraud FDA and nine counts of adulterating drugs at the company’s Noblesville, IN drug compounding facility. The government charged that from 2013 to 2016, Elmer and Caprice R. Bearden, Pharmakon’s former compliance director, caused Pharmakon
Drugs
FDA has granted Janssen Pharmaceutical an accelerated approval for Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. Patients should be
Drugs
Takara Bio has submitted a Drug Master File to FDA for the liquid formulation of RetroNectin GMP grade. The reagent is often used during the manufacturing of CAR T-cell therapies. “In the manufacturing of such therapies, a patient’s T cells — responsible for immune homeostasis — are extracted, modified to
Drugs
Following its review of postmarketing studies, FDA is ordering Sprout Pharmaceuticals to make safety labeling changes for its Addyi (flibanserin) that is indicated to treat acquired, generalized hypoactive sexual desire disorder in postmenopausal women. An agency media statement says that at the time Addyi was approved 8/2015, FDA reviewed
Drugs
The Combination Products Coalition says it would like FDA to confirm that the scope of the agency’s draft guidance on recognition of voluntary consensus standards related to pharmaceutical quality includes combination products under CDER jurisdiction. In its comment letter, the coalition also asks FDA to clarify (1) how the
Drugs
Immuron says it is planning to develop and seek FDA approval for IMM-124E, its bovine polyclonal antibody drug candidate for preventing travelers’ diarrhea (TD). The product under the brand Travelan is approved for this indication in Australia, and it is marketed in the U.S. and Canada as a